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Bladder Relaxant Preparations Therapeutic Class Review (TCR) January 7, 2019 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Manufacturer Indication(s) darifenacin generic, Actavis Treatment of overactive bladder with symptoms of urge urinary (Enablex®)1 incontinence, urgency, and frequency fesoterodine ER Pfizer Treatment of overactive bladder with symptoms of urge urinary (Toviaz®)2 incontinence, urgency, and frequency mirabegron ER Astellas Treatment of overactive bladder with symptoms of urge urinary (Myrbetriq®)3 incontinence, urgency, and urinary frequency Treatment of overactive bladder with symptoms or urge urinary incontinence, urgency, and urinary frequency in combination solifenacin oxybutynin4 generic Relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (e.g., urgency, frequency, urinary leakage, urge incontinence, dysuria) oxybutynin ER generic, Janssen Treatment of overactive bladder with symptoms of urge urinary (Ditropan® XL)5 incontinence, urgency, and frequency; Treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida) oxybutynin hydrochloride gel Actavis/Allergan Treatment of overactive bladder with symptoms of urge urinary (Gelnique®)6 incontinence, urgency, and frequency oxybutynin transdermal Actavis (Rx) Treatment of overactive bladder with symptoms of urge urinary (Oxytrol® [Rx], Oxytrol® for Bayer, MSD (OTC) incontinence, urgency, and frequency Women [OTC])*7 Oxytrol for Women is only approved for use in women (≥ 18 years of age) solifenacin Astellas Treatment of overactive bladder with symptoms of urge urinary (Vesicare®)8 incontinence, urgency, and urinary frequency tolterodine generic, Pfizer Treatment of overactive bladder with symptoms of urge urinary (Detrol®)9 incontinence, urgency, and frequency tolterodine ER generic, Pfizer Treatment of overactive bladder with symptoms of urge urinary (Detrol® LA)10 incontinence, urgency, and frequency trospium11 generic Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency trospium ER12 generic Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency ER = extended-release *In September 2013, oxybutynin transdermal patch (Oxytrol for Women) became available over-the-counter (OTC) for treatment of OAB in women ages 18 years and older.13 It is the first treatment for OAB to become available OTC. Oxytrol patches remain available only by prescription for men. OVERVIEW Overactive bladder (OAB) is a chronic and debilitating syndrome that is characterized by urinary urgency with or without urge incontinence, usually in combination with urinary frequency (8 or more voiding episodes per 24 hours) and nocturia (awakening 1 or more times per night to void).14 The Bladder Relaxant Preparations Review – January 2019 Page 2 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All Rights Reserved. patient fear of urinary incontinence (driven by embarrassment and social stigma) can result in significant changes to a patient’s quality of life (QoL).15 The overall prevalence of OAB occurs equally in men (16%) and women (16.9%); however, more women suffer from OAB with incontinence.16 The prevalence of OAB is almost 20% in those older than 60 years of age. Many conditions are associated with the symptoms of OAB including lower urinary tract conditions (e.g., urinary tract infection, obstruction), neurological conditions (e.g., stroke, Alzheimer’s disease), systemic conditions (e.g., heart failure, vascular insufficiency), functional and behavioral conditions (e.g., impaired mobility), and use of various medications (e.g., diuretics, narcotics). In addition, OAB and urinary incontinence (UI) are associated with skin infections and irritations, and, in the elderly, an increased risk of falls and fractures.17,18,19 In the resting state, the pressure within the bladder is lower than urethral resistance. In the normal individual, the bladder can hold between 350 and 500 mL with the first urge to urinate occurring when the bladder contains around 200 mL. Urination occurs following a sequence of events that begins with a decrease in urethral resistance. Subsequently, the layered smooth muscle that surrounds the bladder (the detrusor muscle) contracts causing the bladder to empty. This sequence of events begins when the bladder's sensory stretch receptors are activated thereby sending signals from the spinal cord to brain centers, resulting in the sensation of urge due to increased bladder filling.20 The symptoms of OAB are usually associated with overactivity of the detrusor muscle as it contracts spastically, sometimes without a known cause. This results in sustained high bladder pressure and urgency or urge incontinence depending on the sphincter response.21 The management of OAB includes both pharmacological and non-pharmacological (e.g., bladder training, pelvic floor muscle exercises) interventions.22,23 Antimuscarinic agents that relax the detrusor muscle or prevent a bladder contraction are effective for OAB. In their 2014 guidelines the American Urological Association (AUA) recommends, behavioral therapy (e.g., bladder training, bladder control strategies, pelvic floor muscle training, and fluid management) as first-line therapy.24 Oral antimuscarinics including darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, or trospium should be offered as second-line therapy. Mirabegron can also be used second-line as it has similar efficacy to the antimuscarinics. Surgery is reserved for patients with severe refractory OAB symptoms or who are not candidates for oral therapy. In 2014, the American College of Physicians (ACP) released a guideline based on a systematic review on the benefits and harms of pharmacologic treatment for urinary incontinence in women.25 The ACP recommends pelvic floor muscle training (PFMT) in women with stress or mixed UI and bladder training in those with urgency UI. Pharmacologic therapy is recommended for urgency UI if bladder training does not achieve desired goals. Drug selection should be based on tolerability, adverse effect profile, ease of use, and cost. The authors concluded that pharmacological agents were similar in their effectiveness at managing urgency UI and had a moderate benefit in reaching continence rates, but pharmacologic agents were affiliated with adverse effects. There was also evidence that showed some patients were likely to stop pharmacological treatment due to adverse effects. Data were insufficient to compare most agents with one another for safety and efficacy. However, solifenacin had the lowest risk of discontinuation from adverse effects and oxybutynin had the highest risk of discontinuation. Risk for discontinuation for darifenacin and tolterodine were similar to placebo. Bladder Relaxant Preparations Review – January 2019 Page 3 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All Rights Reserved. In September 2013, oxybutynin transdermal patch (Oxytrol for Women) became available for over-the- counter (OTC) use to treat OAB in women. The transdermal patch (Oxytrol) is available with a prescription to treat OAB in men and women. The OTC product was not approved for use in men due to the concern of prostate related complications. PHARMACOLOGY26,27,28,29,30,31,32,33,34,35,36,37 Contractility of the human detrusor muscle is predominantly controlled by the parasympathetic nervous system. Although other neurotransmitter pathways are involved, acetylcholine is the major peripheral neurotransmitter responsible for bladder contraction. Acetylcholine causes this response through its interaction with
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